SENSITIVITY AND SPECIFICITY OF A DNA-POLYMERASE CHAIN-REACTION NONISOTOPIC-BASED DETECTION METHOD FOR THE CONFIRMATION OF INFECTION WITH HUMAN T-LYMPHOTROPIC VIRUS TYPE-I AND TYPE-II

Background: A convenient, standard format for the detection of polymer ase chain reaction (PCR) amplicons would increase the use of PCR for t he confirmation of infection with human T-lymphotropic virus types I a nd II (HTLV-I and HTLV-II). Objectives: To determine the sensitivity a nd specificity of an enzyme oligonucleotide assay (EGA) for the confir mation of infection with HTLV-I or HTLV-II. Study design: The sensitiv ity of the EOA was determined by examining 88 specimens representing d iverse geographic-associated genotypes and clinical manifestations. Th e specificity was determined by testing 40 HTLV-seroindeterminate (PCR -negative) specimens. Results: Of the 52 HTLV-I-positive specimens tes ted, 46 (88%) were confirmed positive for HTLV-I by the EGA; these inc luded 25 of 30 (83%) specimens from asymptomatic carriers, 14 of 15 (9 30/0) specimens from patients with HTLV-I-associated myelopathy, and a ll 7 specimens from patients with adult T-cell leukemia. Similarly, 33 of 36 (92%) HTLV-II-posilive specimens were confirmed positive for HT LV-II. None of the specimens werewrongly classified. All specimens tes ted with distinct geographic-associated genotypes for HTLV-I and -II w ere detected by EGA. Analysis of seroindeterminate specimens, all of w hich were previously shown to be negative by nested PCR, showed that n one of 40 were detected by either the HTLV-I or HTLV-II EGA.